Pilot Study of a Decision Aid Intervention for Family-building After Cancer
NCT ID: NCT04059237
Last Updated: 2024-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2020-01-06
2022-12-11
Brief Summary
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Detailed Description
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Primary Objective: Examine feasibility and acceptability of a decision aid intervention in a single-arm pilot trial.
Secondary Objective: Obtain preliminary effect sizes of the decision aid intervention using a pre-post study design.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Online Decision Aid
web-based psychosocial assessment questionnaires will be administered at baseline (T1; pre-intervention) and at one-month (T2) and three-month (T3) follow-up time points.
Web based decision aid intervention
Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.
Interventions
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Web based decision aid intervention
Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.
Eligibility Criteria
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Inclusion Criteria
* Completed cancer treatment known to have gonadotoxic effects (e.g., systemic chemotherapy, surgery affecting reproductive organs or hormone regulation, and/or pelvic radiation)
* Understands verbal and written English
* Desires future children or uncertainty regarding family-building plans
* Access to the Internet and use of a computer, tablet, or smartphone
Exclusion Criteria
* Significant physical or mental disability that prevents completion of study activities
Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility preservation, egg extraction for surrogacy, or pregnancy for some patients, and because patients may be interested in alternative family-building options such as surrogacy or adopting.
18 Years
45 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
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Catherine Benedict
Clinical Associate Professor, Psychiatry and Behavioral Sciences- Medical Psychiatry
Principal Investigators
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Catherine Benedict
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Cancer Center
Stanford, California, United States
Countries
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References
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Benedict C, Ford JS, Schapira L, Simon P, Spiegel D, Diefenbach M. Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study. BMJ Open. 2019 Dec 29;9(12):e033630. doi: 10.1136/bmjopen-2019-033630.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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VAR0190
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-52143
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-52143
Identifier Type: -
Identifier Source: org_study_id
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